Office of Research Services
Office of the Vice Chancellor for Research
304 Administrative Office Building, MC 672
1737 West Polk
Chicago, Illinois 60612
An Open Letter to our Sponsors for Clinical Trials:
Thank you for selecting the University of Illinois at Chicago for this study. The Office of Research Services
(ORS) will review your contract, and work towards concluding the clinical trial agreement with you shortly.
UIC, like other public research universities is subject to an increasing number of state and federal
regulations that are unique to higher education. As a result, most contracts provided by our sponsors
require revisions before we can legally sign them.
For your convenience, we have attached a summary of the most common provisions negotiated in clinical trial
agreements.
To avoid unnecessary delays, ORS will soon send you our proposed revisions in redline form. During the review
process, ORS will consult with the Office of University Counsel regarding the agreement.
Should you have further questions regarding this process, you may contact ORS directly:
Office of Research Service
Pre-Award Contracts
312-996-2862
We look forward to working with you on this clinical trial agreement. If I can be of assistance, please do not
hesitate to call me.
Very truly yours,
Patricia Pfister
Associate Director
Office of Research Services
Office of Research Services
Phone (312) 996-2862
Fax
(312) 996-9005
Email awards@uic.edu
Web research.uic.edu
CONTRACT ISSUES CLINICAL TRIAL
AGREEMENTS
Contracting party
The Board of Trustees of the University of Illinois is the contracting entity. Our
name should appear in the Clinical Trial Agreement (CTA) as follows:
“The Board of Trustees of the University of Illinois on behalf of the University of
Illinois at Chicago”. If an address is needed in the preamble, please use the
following: “having offices at 1737 W. Polk Street, 304 AOB Building, Chicago,
IL 60612-7227”. The Principal Investigator is an employee of the University
and therefore is not named as a party to the CTA.
Term of Agreement
For University accounting purposes, there must be an estimated termination date
for the CTA.
Governing Law
As a state entity, we cannot agree to the governing law of another state other than
Illinois. In the alternative, we can remain silent on this provision.
Intellectual Property
The University is limited by its own Intellectual Property Policy as to what
inventions may be assigned to a sponsor of research. The University cannot
agree to broad ownership language that allows the sponsor to own inventions that
“result from” or “arise out of” the clinical trial.
Confidentiality
The University is a state entity and is therefore subject to Illinois Freedom of
Information Act laws. It is in the best interest of the sponsor to mark its written
confidential information as “CONFIDENTIAL” and oral communications for
which sponsor wishes to be considered as its confidential information should be
reduced to writing within thirty (30) days of the oral communication and marked
as “CONFIDENTIAL”.
The University’s obligations of confidentiality with respect to sponsor’s
confidential information must have a termination point. The University is
acceptable to a limit of five (5) years after the termination of the CTA.
Indemnification
The University expects that the Sponsor will indemnify and hold harmless the
University, its trustees, Principal Investigator, officers, agents and employees
from any and all liabilities, claims, actions or suits made by third parties arising
from the University’s performance of the clinical trial, including the Sponsor’s
use of the Study data, results and inventions and the negligence or willful
misconduct of the Sponsor (and the CRO, if any). Indemnification by the
University will be limited to the extent permitted by Illinois law, and only for
University’s negligence or non-compliance with applicable laws.
Insurance
To support the sponsor’s indemnification obligations the sponsor must maintain a
sufficient level of insurance (e.g., $3 million dollars per occurrence). The
University is self-insured – see plan documents at University of Illinois Liability
Self-Insurance Plan.
Arbitration
The University cannot agree to binding arbitration or mediation as the form of
dispute resolution.
Disclaimer of Warranties
As the performance of a clinical trial is considered research, we must explicitly
disclaim certain warranties that may attach by operation of law. The disclaimer
that appears in our research contracts are as follows:
INSTITUTION MAKES NO REPRESENTATIONS OR WARRANTIES,
EXPRESS OR IMPLIED, REGARDING ITS PERFORMANCE UNDER THIS
AGREEMENT. INSTITUTION DISCLAIMS ANY WARRANTY OF
MERCHANTABILITY, USE OR FITNESS FOR ANY PARTICULAR
PURPOSE AND NON-INFRINGEMENT OF ANY INTELLECTUAL
PROPERTY RIGHTS WITH REGARD TO STUDY DATA, RESULTS,
INVENTIONS, COPYRIGHTABLE WORKS, TANGIBLE RESEARCH
PROPERTY, OR OTHER RESEARCH RESULTS PROVIDED BY
INSTITUTION.
Adverse Events
The University requires that the Sponsor report to the University adverse events
the Sponsor becomes aware of during and after the clinical trial. Sample
language follows:
The Sponsor must promptly report to the University any and all findings that
could affect the safety or medical care of Research subjects or their willingness
to continue participation in the Research, alter the conduct of the Research, or
alter the University’s institutional review board’s approval of the Research. Such
findings shall include, but not be limited to, any study-related illness, adverse
event, or injury that results in a claim for payment for treatment. The Sponsor
acknowledges and agrees that the University may be required to report such
findings to 1) the appropriate federal government authorities as may be required
under applicable federal law or regulation and 2) the Research subjects. During
the Research and after the conclusion of the Research, the Sponsor will continue
to inform the University of observed Research study drug(s) or device(s) effects
so the University, if appropriate, can inform the Research subjects.
Limitation of Liabilities
As a state entity subject to laws that limits the University’s ability to take on
liabilities over and above the amount in its treasury, the University must
specifically exclude any contingent unlimited liability that may or may not be
covered by legislative appropriations or any funds the University may have on
hand. Following is sample limitation of liability language that is in all of our
research contracts:
INSTITUTION SHALL NOT BE LIABLE TO SPONSOR FOR INDIRECT,
SPECIAL, CONSEQUENTIAL, PUNITIVE, INCIDENTAL OR OTHER
DAMAGES (INCLUDING LOST REVENUE, PROFITS, USE, DATA OR
OTHER ECONOMIC LOSS OR DAMAGE) HOWEVER CAUSED AND
REGARDLESS OF THEORY OF LIABILITY (WHETHER FOR BREACH OR
IN TORT, INCLUDING NEGLIGENCE) ARISING FROM, RELATED TO,
OR CONNECTED WITH SPONSOR’S USE OF RESEARCH DATA,
RESULTS, INVENTIONS, COPYRIGHTABLE WORKS, TANGIBLE
RESEARCH PROPERTY, OR ANY OTHER RESEARCH RESULTS
PROVIDED BY INSTITUTION, EVEN IF INSTITUTION WAS ADVISED OF
THE POSSIBILITY OF SUCH DAMAGE.
Subject Injury
Sample Subject Injury Language: The Sponsor shall reimburse the Institution or
the Subjects for reasonable and necessary medical expenses incurred by Subjects
for any medical care, including hospitalization, in the treatment of any illness or
injury sustained by the Subjects directly resulting from a Subject’s participation
in the Study; provided, however, the foregoing shall not apply to the extent the
expenses, illness, or injury arise from the Institution’s negligence.
Payment
Make Checks Payable to: The Board of Trustees of the University of Illinois
Mail To:
University of Illinois at Chicago-Grants and Contracts
28395 Network Place
Chicago, IL 60673-1283
Signature Line
The Board of Trustees of the University of Illinois
________________________
__
Authorized Official: Walter K. Knorr, Comptroller
Administrative Contact
Director
UIC Office of Research Services
1737 W. Polk Street, 304 AOB Building
Chicago, IL 60612-7227
Email: awards@uic.edu
Phone: (312) 996-2862
Fax: (312) 996-9005